Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-10

Study Completion Date

2032-02-06

Brief Summary

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This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.

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Detailed Description

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During your surgery, after your lump is removed, the surgeon will place the SIRA-1000 in the breast cavity and perform the RF ablation procedure to treat the margins of the lumpectomy surgical site. A stitch will be used to stabilize and secure the tissue around the neck of the SIRA-1000 to ensure that contact is maintained between the SIRA-1000 electrode array and cavity tissue.

Upon completion of the RF ablation treatment, your tumor and the tissue samples from the ablated edges of the surgical site will be sent for review under a microscope (pathology).

After this, your surgery will be completed as standard, and your discharge will be determined by your medical team like any other surgery.

Conditions

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Breast Cancer Breast-conserving Surgery Breast Cancer - Infiltrating Ductal Carcinoma ER/PR+Her2neu Grade I, II, III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Safety study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Feasibility and safety study for women undergoing BCS.

RFA electrosurgical device as an adjunct to BCS.

Group Type EXPERIMENTAL

Radiofrequency ablation alone

Intervention Type DEVICE

Demonstrate the accuracy of the device to produce approximately 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation tissue samples at least 1cm deep.

Radiofrequency ablation Electrosurgical Device

Intervention Type DEVICE

SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Interventions

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Radiofrequency ablation alone

Demonstrate the accuracy of the device to produce approximately 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation tissue samples at least 1cm deep.

Intervention Type DEVICE

Radiofrequency ablation Electrosurgical Device

SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Biologic female
2. 50 years of age and older
3. Confirmed diagnosis of breast cancer:

1. Infiltrating ductal carcinoma
2. ER/PR+Her2neu-
3. Grade I, II, or III
4. Unicentric, unilateral tumor size ≤ 3cm
5. Tumor location ≥ 2 cm from skin and other structures
6. Zubrod Performance Status of 0, 1, or 2
7. No palpable lymphadenopathy
8. Able and willing to provide written informed consent

Exclusion Criteria

1. Pregnant or breastfeeding
2. Neoadjuvant chemotherapy
3. Cardiac arrhythmia
4. Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
5. Current or history of breast implants
6. Multi-centric or bilateral breast cancer
7. Diffuse microcalcifications
8. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
9. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No